Business · 15/07/2009Updated: 10/17/2026 · 1 min read
FDA Releases Revised Guidance on Impurities in Drug Substances for Industry
Summary
The Food and Drug Administration (FDA) has made available a revised guidance for industry on reporting impurities in drug substances, which is intended to help pharmaceutical companies prepare original abbreviated new drug applications (ANDAs) and other submissions.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →